| submitted | available | document details (if available) | source link |
|---|---|---|---|
| August 28 2019 | August 28 2019 | Adobe PDF Library 15.0 |
| various | User Manual | Users Manual | 2.37 MiB | August 28 2019 |
GCE HEALTHCARE Portable Oxygen Concentrator Models: RS-00600 & RS-00600C User Manual English . 2 Deutsch . 38 Franais . 78 Nederlands . 118 Espaol . 158 Portugus . 196 Italiano . 236 Svenska . 274 EN DE FR NL ES PT IT SV EN English User manual: Zen-O lite Portable Oxygen Concentrator (Models: RS-00600/RS-0600C) CONTENT 1. Foreword . 4 1.1. General Information . 4 1.2. Classi cation . 4 1.3. Typographical Conventions . 5 2. Intended Use . 5 3. Safety Instructions . 6 3.1. Warnings Overview . 6 3.2. Cautions Overview . 7 3.3. Important Information . 9 4. Instructions and Training . 9 5. Product Description. 10 5.1. Schematic Description . 10 6. General Instructions Before Use . 11 6.1. Accessories List . 11 6.2. Battery . 11 6.3. Nasal Cannula . 13 7. Operating Zen-Olite . 14 7.1. Connecting a Nasal Cannula . 14 7.2. Turning On . 15 7.3. Choosing a Preferred Language . 15 7.4. Adjusting Setting . 15 7.5. ECO Mode . 16 7.6. Battery Button . 16 7.7. Responding to Alarms . 16 7.8. Turning O . 17 2/316 EN 8. Traveling with the Zen-Olite POC by Air . 17 8.1. Passenger Pre- ight Preparation . 17 8.2. Boarding and In- ight Information . 19 8.3. Transportation Security Administration (TSA) Requirements . 20 8.4. Placing your device in Airplane Mode . 21 9. Alarm Indicators . 22 9.1. Alarms . 23 10. Troubleshooting . 26 11. Maintenance and Cleaning . 27 11.1. Routine Maintenance . 27 11.2. Cleaning and Disinfection . 27 11.3. Service Life . 27 11.4. Service Connector . 27 12. Device Repair and Disposal . 28 12.1. Repair . 28 12.2. Sieve Modules Replacement Instructions: . 28 12.3. Disposal . 29 13. Warranty . 29 14. Trademarks and Disclaimer . 29 14.1. Trademark . 29 14.2. Disclaimer . 29 15. Technical Description . 30 15.1. Electromagnetic Compatibility (EMC) Information . 33 15.2. FCC warning statement for model RS-00600C: . 36 15.3. EU red article 10(10) restrictions on use for model RS-00600C: . 38 15.4. RF exposure information: . 38 16. Glossary - Explanation of Packaging and Labelling Symbols . 40 3/316 EN 1. FOREWORD Please refer to this manual for detailed instructions on warnings, cautions, speci ca-
tions, and additional information. Important: Users should read this entire manual before operating the Zen-Olite Port-
able Oxygen Concentrator. Failure to do so could result in personal injury and/or death. If you have questions about the information in this user manual or about the safe opera-
tion of this system, contact your distributor. 1.1. General Information This user manual provides information for users of the Zen-Olite Portable Oxygen Con-
centrator. For the sake of brevity, the terms concentrator, "POC", unit, or device are sometimes used in this document to refer to the Zen-Olite Portable Oxygen Concentra-
tor. "Patient" and "User" are used interchangeably. 1.2. Classi cation This device is listed with an internationally recognised testing laboratory and classi ed with respect to electric shock, re, and mechanical hazards in accordance with the fol-
lowing standards:
IEC/EN 60601-1:2012, Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance. IEC/EN 60601-1-2:2014, Part 1-2: General Requirements for Safety Collateral Standard:
Electromagnetic Compatibility Requirements and Tests. IEC/EN 60601-1-6:2010+A1:2013 Medical Electrical Equipment Part 1-6: General Requirements for Basic Safety and Essential Performance Collateral Standard:
Usability. IEC/60601-1-8:2006 Medical Electrical Equipment Part 1-8: General Requirements for Safety Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems. IEC/60601-1-11:2011 Medical Electrical Equipment - Part 1-11: General Requirements for Safety - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment. ISO 80601-2-67:2014, Medical Electrical Equipment - Part 2-67: Particular Requirements for Basic Safety and Essential Performance of Oxygen Conserving Equipment. ISO 80601-2-69:2014, Medical Electrical Equipment - Part 2-69: Particular Requirements for Basic Safety and Essential Performance of Oxygen Concentrator Equipment. CAN/CSA C22.2 No. 60601-1:14, Canadian Standard, Medical Electrical Equipment -
Part 1: General Requirements for Basic Safety and Essential Performance. RTCA DO-160G:12/8/2010 Environmental Conditions and Test Procedures for Airborne Equipment. 4/316 ISO 7637-2:2011 Road Vehicles - Electrical disturbances from conduction and coupling-
Part 2: Electrical transient conduction along supply lines only. Medical Device Directive 93/42/EEC. This equipment is classi ed as:
Class II Class IIa according to the MDD 93/42/EEC Type BF IP22 with the carry bag 1.3. Typographical Conventions This user manual contains warnings, cautions, and notes to help call attention to the most important safety and operational aspects of the device. To help identify these items when they occur in the text, they are shown using the following typographical conventions:
WARNING: Statements that describe serious adverse reactions and potential safety hazards. CAUTION: Statements that call attention to information regarding any special care to be exercised by the practitioner and/ or patient for the safe and e ective use of the device. IMPORTANT: Statements calling attention to additional signi cant information about the device or a procedure. EN 2. INTENDED USE Zen-Olite portable oxygen concentrator is intended to provide supplemental oxygen to patients with chronic pulmonary diseases and any patient requiring supplemental oxy-
gen. The device is portable, enabling patients who need an oxygen device to be treated at home according to a clinicians prescription or direction. Zen-Olite is not intended for use in life supporting or life sustaining situations, and is provided non-sterile. It is a prescription only device, and designed for indoor and outdoor use. For correct operational conditions see Chapter 15. Technical Description. Zen-Olite Portable Oxygen Concentrator is not intended to be used:
in life-supporting or life-sustaining situations in an operating or surgical environment with a non-adult population in conjunction with ammable anaesthetic or ammable materials 5/316 EN 3. SAFETY INSTRUCTIONS 3.1. Warnings Overview 1. The device must be used in the carry bag to provide protection from liquid intrusion 2. There is a risk of re associated with oxygen equipment and therapy. Do not use from rain and/or spills. near sparks or open ames. 3. The settings of Zen-O lite Portable Oxygen Concentrator RS-00600/RS-0600C might not correspond with continuous ow oxygen. 4. The settings of other models or brands of portable oxygen concentrators do not cor-
respond with the settings of Zen-Olite Portable Oxygen Concentrator RS-00600/
RS-0600C. 5. Wind or strong drafts can adversely a ect accurate delivery of oxygen therapy. 6. Geriatrics or any other patient unable to communicate discomfort can require addi-
tional monitoring to avoid harm. 7. Smoking (including e-cigarettes) during oxygen therapy is dangerous and is likely to result in facial burns, serious injury or death of the patient and others from re. Do not allow smoking or open ames within the same room as the portable oxygen con-
centrator or any oxygen carrying accessories. If you smoke, you must always turn the oxygen concentrator o , remove the cannula and leave the room where either the cannula or the concentrator is located. If unable to leave the room, you must wait 10 minutes after the ow of oxygen has been stopped. 8. Use only water based lotions that are oxygen compatible, before and during oxygen therapy. Never use petroleum or oil based lotions or salves when operating the de-
vice to avoid the risk of re and burns. 9. Open ames during oxygen therapy are dangerous and are likely to result in re or death. Do not allow open ames within 3 metres (10 feet) of the oxygen concentrator or any oxygen carrying accessory. 10. Oxygen makes it easier for a re to start and spread. Do not leave the nasal cannula on bed coverings or chair cushions with the concentrator on, but not in use; the oxy-
gen will make the materials ammable. Turn the concentrator o when not in use to prevent oxygen enrichment. 11. Explosion hazard. Do not use in the presence of ammable anaesthetics!
12. Do not use this device in the presence of pollutants or fumes. 13. Do not submerge this device in liquid. Do not expose to water or precipitation. Do not expose to dusty conditions. 6/316 EN 14. Do not use a device or any accessory that shows any sign of damage. 15. Do not use lubricants on this device or any of its accessories. 16. Use of this device at an altitude above 4,000 m (13,000 feet), or outside the tem-
perature range of 5C (41F) to 40C (104F), or outside the humidity range of 5% to 93% may adversely a ect the owrate and percentage of oxygen and consequently the quality of therapy. When not in use, the device should be stored in a clean, dry environment between -20C and 60C (-4F and 140F). Use and/or storage outside of the valid conditions may damage the product. For more technical details see Chapter 1515. Technical Description. 17. Always ensure the battery is inserted before using this device. 18. If feeling ill or experiencing discomfort while using this device, contact your clinician or seek medical assistance immediately to avoid harm. 19. Your home oxygen provider must verify the compatibility of the device and all acces-
sories used prior to use. To ensure you are receiving the therapeutic amount of oxy-
gen for your medical condition, the device and accessories must only be used after one of more settings have been determined or prescribed for you at your speci c activity levels by a healthcare professional. 20. The electrical cord and tubing could present a tripping or strangulation hazard. Keep away from children and pets. 21. Do not disassemble or modify this device or any of its accessories. Do not attempt any maintenance other than tasks described in Chapter 10 - Troubleshooting. Disas-
sembly can create an electric shock hazard and will void the warranty. Contact your distributor for servicing by authorised personnel. 22. Use only spare parts recommended by the manufacturer to ensure proper function and to avoid the risk of re and burns. 23. Do not repair or perform service work while the device is in use by the patient. 24. Do not position your device and its power supply such that it is, di cult to unplug from the power source in the event of an emergency or it is di cult to isolate the device in the event of a re, electrical hazard or any other incident. 7/316 EN 3.2. Cautions Overview 1. Keep away from heat sources ( replaces, radiant heaters, etc.) that could cause the operating temperature at or near the device to exceed 40C (104F). 2. The display may be di cult to read under bright lighting conditions (sunlight, interior lights, etc.), move away from direct light for viewing the display. 3. Keep away from lint or other loose material that could block the air intake vents. 4. Some countries restrict this device to be sold by or on an order of a prescribing clini-
cian. Please ensure you comply with relevant local laws. 5. Non-prescribed oxygen therapy can be hazardous under certain circumstances. Use this device only when prescribed by a clinician. 6. Patients with a fast breathing rate requiring a higher oxygen setting may require more oxygen than this device can produce - see Chapter 15 - Technical Description. This device may not be appropriate in that case. Consult your clinician for alternative treatment. 7. Always operate the device at the setting prescribed by a clinician. Do not alter the setting unless prescribed by a clinician. Periodic reassessment of the ow settings should be done by a clinician. 8. Do not use this device while sleeping unless prescribed by your clinician. 9. It is recommended for an alternate source of oxygen to be made available in the event of power outage or mechanical failure. Consult your home oxygen provider or clinician for an appropriate backup system. 10. This device may not reach speci ed oxygen concentration purity until it has been in use for up to 2 minutes at set owrate. Additional warm up time of up to 30 minutes may be required to reach an optimum oxygen purity level, if the device has been stored/unused for an extended period or kept in cold temperatures. 11. This device is designed for use by one patient at a time. 12. If you are unable to hear or see alarms, do not have normal tactile sensitivity, or can-
not communicate discomfort, consult a clinician before using this device. 13. If oxygen concentration drops below the speci ed level, an alarm will indicate this condition. If alarm persists, stop using this device, switch to an alternate source of oxygen, and contact your home oxygen provider. 14. Only use approved accessories with this device. See approved accessories list in section 6.1 and cannula approved for use with this device. Using unapproved acces-
sories or cannula may impair the performance of this device. 15. This device is not designed for use with a humidi er or nebuliser. If a humidi er or nebuliser is used with this device, performance may be diminished and the device may be damaged. 8/316 EN 16. Always follow the cannula manufacturers instructions for proper use. 17. Replace the cannula on a regular basis. Check with your home oxygen provider or clinician to determine how often the cannula should be replaced. 18. Check that this device operates on battery after disconnecting from the power source. 19. Only charge battery in this device or in an approved charger. (See approved acces-
sories list.) battery in a cool, dry place. 20. Remove battery if this device is not going to be used for more than seven days. Store 21. Do not use cleaning agents other than those speci ed in this manual. Allow the clean-
ing solution to dry from the cleaned surface before use. 22. Always turn o this device when not in use. 23. Always disconnect power and turn o this device before cleaning, see Chapter 11 -
Maintenance and Cleaning 24. Do not obstruct air intake or exhaust vents when operating this device. Blockage can cause buildup of internal heat and shut down or damage this device. 25. Do not place objects on top of this device. 26. Keep away from children and pets to prevent damage to the device and accessories and/or inadvertent setting changes. 27. Keep the device away from pets and pests. 28. This device is rated IP22 while used in the carry bag. Do not use in dusty or wet con-
ditions. tenance. 29. Always use in a well ventilated location. 30. Always follow the maintenance schedule as speci ed in section 11.1 - Routine Main-
31. If this device indicates an abnormal condition, see Chapter 10 - Troubleshooting. 32. Use caution when touching this device in high ambient temperatures. 33. The device can be re-used by a new patient. The device should be cleaned as indi-
cated in section 11.2 of this user manual and, according to local laws and prescrip-
tions prior to delivering to a new patient. 34. The device can be isolated from power by disconnecting the power supply from the input connector, see g. 1, position the device for easy access to the power supply input connector. 9/316 EN 3.3. Important Information 1. If an extension cord is necessary, use a UL listed 15 amp or higher cord. Do not con-
nect any other devices on the same extension cord. Do not use a multisocketed extension cord. 2. Inhale through the nose for the concentrator to work most e ectively. Inhaling through the mouth may result in less e ective oxygen therapy. 3. Your device is designed for everyday use, for optimum performance use your device for a minimum of 4 hours a day. 4. INSTRUCTIONS AND TRAINING The Medical Devices Directive 93/42/EEC states that the product provider must ensure that all users of the device are provided with the User Manual. The User Manual for this device has been written to account for training and knowledge of the patient population in order to operate the device appropriately. WARNING: Do not use the product without rst reading the user manual. Do not oper-
ate this device if unsure of its operation or function. Contact your home oxygen pro-
vider for assistance or further information. 10/316 5. PRODUCT DESCRIPTION 5.1. Schematic Description Alarm mute indicator Display screen Green LED - power ON Power button Breath detect LED Red LED - warning Yellow LED - warning Pulse setting selection buttons EN Battery indicator Air intake Alarm mute button Battery Nasal cannula port Power input Exhaust vent Battery cover Fig. 1 11/316 Battery release button EN 6. GENERAL INSTRUCTIONS BEFORE USE A variety of accessories can enhance the portabil-
ity and use of the Zen-O lite Portable Oxygen Concentrator. In addition to the device, the pack-
age contains accessories to get started and a user manual. Contact your home oxygen provider for a complete list of available accessories. Always inspect the device and its accessories for any sign of damage before use. Important: While the box or packaging may exhib-
it some damage, e.g., tears or dents, the device may still be in a usable condition. If the device or any accessory shows any sign of damage, contact your home oxygen provider. Before you get started, check to make sure you have the following:
Concentrator Battery Carry bag Accessory bag AC power supply DC power supply 6.1. Accessories List Only use power supplies/adapters or accessories speci ed in this manual. Using accessories that are not speci ed may create a hazard and/or neg-
atively a ect the performance of the device. 12/316 Fig. 2 Power supply Fig. 3 EN Rechargeable battery (RS-00601) AC power supply European cord AC power supply United Kingdom
(RS-00602) cord (RS-00603) AC power supply North America cord AC power supply without cord
(RS-00604)
(RS-00612) European power cord (RS-00504) United Kingdom cord (RS- 00506) North America cord (RS-00503) External battery charger
- European (RS-00516) External battery charger
- North America (RS-00515) External battery charger
- United Kingdom (RS-00517) DC power supply (RS-00605) Carry bag (RS-00606) WARNING: Do not use the device or any accessory that shows any sign of damage. 6.2. Battery Zen-Olite Portable Oxygen Concentrator can always be used when directly connected to a power source. However, to enhance its portability, the concentrator is equipped with a rechargeable lithium-ion internal battery. WARNING: Always ensure the battery is inserted before using this device. IMPORTANT: Optional power cords are available for various global use and travel (see Section 6.1 - 6.1. Accessories List). 6.2.1. Charging the Battery CAUTION: Only charge the battery in this device or in an approved charger section 6.1
- 6.1. Accessories List.). Prior to using the device for the rst time, install the battery as shown in Fig. 2. the bat-
tery will latch when fully seated. Close the battery compartment ensuring the cover latches to the device. Connect the AC/DC power supply by plugging the round connector into the power in-
put on the side of the concentrator Fig. 3. Plug the other end of the AC/DC power supply into a power outlet. Always use caution when inserting the power supply to a wall outlet. The display shows The charger is universal and supports a wide variety of international markets, so it can be plugged into an outlet with 100-240V AC, 50-60 Hz. Allow the battery/batteries to fully charge before rst time use. Once completely charged, the device can run for up to 4 hours on battery power, at setting 2 and 18 breaths per minute. 13/316 EN IMPORTANT: Battery run time may vary based on breathing rate, age of battery, and environmental conditions. See displayed text on device for battery charge status. IMPORTANT: Ensure power status icon (see Fig. 7) indicates power is connected. If not, check that cord is plugged in completely (see Chapter 10 - Trouble shooting for more information) To maximise battery life and run time, avoid letting the battery deplete and use while connected to a power source whenever possible. The battery will automatically charge whenever the concentrator is connected to a power source. You can use the device while the battery is charging. The LCD display will indicate whether the device is operat-
ing on battery or external AC power. The fully charged battery will retain some level of charge for up to thirty days in this de-
vice when not in use - see Caution below for battery removal/storage recommendation. IMPORTANT: Battery damage may result if the concentrators battery is allowed to dis-
charge completely. IMPORTANT: After 300 charge/discharge cycles, the battery capacity will be at least 80% of its original capacity. Replace the battery when the reduced battery life is a ect-
ing your mobility. IMPORTANT: The DC power supply should be utilised on vehicles with the proper power output rating. IMPORTANT: The vehicle should be running while utilising the DC adapter to power the Zen-Olite Portable Oxygen Concentrator. CAUTION: Remove battery if this device is not going to be used for more than seven days. Store battery in a cool, dry place. CAUTION: Check that this device operates on battery after disconnecting from the pow-
er source. IMPORTANT: When not using the battery inside the unit, be sure to store it in the protec-
tive sleeve that was provided with the original package. If the battery will not be utilised for long durations, charge the battery fully at a minimum of once per year. 14/316 6.3. Nasal Cannula Only use a nasal cannula with the following speci cations:
Length: 1.2m (4ft), 2.1m(7ft) or 7.6m(25ft) High ow Crush resistant Large internal diameter bore Suitable for up to 15 litres per minute (lpm) at a max. pressure of 3.6 psi Meets substance compatibility of IEC/EN 60601-1 CAUTION: Only use approved accessories with this device. Refer to the approved ac-
cessories guide for a complete list of accessories and cannula approved for use with this device. Using unapproved accessories or cannula may impair the performance of this device, including ow rate or oxygen purity. Contact your distributor for updated information and accessories or if additional, option-
al, or replacement accessories are needed. EN 7. OPERATING ZENOLITE IMPORTANT: Read Chapter 3. Safety Instructions before using this device. Zen-Olite Portable Oxygen Concentrator is designed for ease of use, with all functions accessed through just a few buttons on the control panel. The device should be carried in its carry bag and used when positioned upright on a at surface or on the oor while in the carry bag. The patient should be within the recom-
mended cannula length during use. IMPORTANT: Except during startup and shutdown sequences, the backlight on the dis-
play screen will remain o . Pressing any button will turn the backlight on brie y. The backlight will also remain activated during an un-muted alarm condition. 7.1. Connecting a Nasal Cannula CAUTION: Replace the cannula on a regular basis. Check with your home oxygen pro-
vider or clinician to determine how often the cannula should be replaced. CAUTION: Always follow the cannula manufacturers instructions for proper use. Connect the tubing to the cannula port as shown in Fig. 5. To connect the cannula to the patient, position the cannula tips in patients nostrils and pass tubing over both ears and under chin. Follow manufacturers instructions. Slide adapter up tubing to adjust for comfort and t. Once the cannula is secured, breathe normally through the nose. Zen-Olite will detect a breath and deliver the oxygen during inhalation. 15/316 IMPORTANT: Improper cannula placement may result in the device being unable to detect all respiratory e orts of the patient. Ensure cannula is connected securely and it has been fully inserted. 7.2. Turning On To turn the device on, press the power button The concentrator will chirp and the green, yellow, and red LEDs will ash once, while the screen displays the device name. EN Red LED - indicates a warning danger and/or a need for urgent action Red LED - indicates a warning danger and/or a need for urgent action Yellow LED - indicates caution or attention required Cannula port Flashing green LED - indicates oxygen is being delivered. Flashing green LED - indicates oxygen is being delivered. Fig. 5 IMPORTANT: No adjustments can be made until the startup sequence is completed. 7.3. Choosing a Preferred Language While the device is on, hold down the plus and mute buttons together for approximately four seconds until it says Language:. Next cycle through the available languages using the plus or minus buttons. Fig. 6 When the desired language is shown, press the battery but-
to select. The device will change the language and ton go back to the normal ow screen. 7.4. Adjusting Setting IMPORTANT: After powering on Zen-Olite, the startup sequence will take approximate-
ly 35 seconds. Speci ed oxygen level will be reached within 2 minutes of use. The device starts working in the previous setting. The device will deliver a pulse of oxygen at the beginning of each of your inhalation. Auto Mode: If no inhalation is detected for 60 seconds when in pulse mode, the Check Cannula alarm will be activated and the device will automatically enter Auto-Mode and continue to deliver oxygen at a rate of 18 breaths per minute. When an inhalation is detected, the device will clear the Check Cannula alarm and exit Auto-Mode. Pulse mode of operation can be adjusted from 1.0 to 5.0 in 0.5 increments with the and buttons. 16/316 IMPORTANT: If an air leak is suspected, leaks can be detected with a solution of soap and water applied to the cannula-concentrator connection point and looking for bub-
bles. The current setting and power source (external power or battery; battery icon also shows approximate level of charge remaining) are shown on the display screen as shown in Fig. 7. Zen-Olite operating on battery power. Fig. 7 Zen-Olite running on external power. EN 7.5. ECO Mode While the Setting screen is shown, press and hold the Battery button for approximately four seconds until it changes from Pulse XX to Eco Mode. Press and hold the Battery button again to return to Pulse Mode. At startup, the device will always default to stand-
ard Pulse Mode. In standard Pulse Mode, the device will give you the same amount of oxygen every breath, regardless of your breath rate. This can consume more battery power at higher breath rates. In Eco Mode, the device will deliver a xed volume of oxygen per minute regardless of breath rate, and will give an extended battery duration. 7.6. Battery Button The battery button the button will cycle through all the information. First, the gauge information will be shown Next allows you to check the status of the battery. Repeatedly pushing the number of charge cycles will be shown or or
. After the third push of the battery button, the display will alternate back to the main screen showing the current ow setting. It will also automatically exit the battery status menu and go back to the main ow setting display after approximately 15 seconds of no buttons being pushed. 17/316 EN 7.7. Responding to Alarms CAUTION: If you are unable to hear or see alarms, do not have normal tactile sensitivity, or cannot communicate discomfort, consult your clinician before using this device. at any time will silence the buzzer. The length of the Pressing the alarm mute button mute period depends on the severity of the alarm (see Chapter 9 - Alarm Indicators). Dur-
ing this mute period, the mute LED will remain illuminated, indicating the alarm buzzer is muted. Push the mute button again to un-mute alarms. Pressing the mute button when there is no active alarm will mute any future medium or low priority alarms for eight hours. See Chapter 9 - Alarm Indicators and Chapter 10 - Troubleshooting for additional informa-
tion on alarms. IMPORTANT: The alarm system is tested during the startup sequence. You should see all alarm lights brie y turn on and the audible alarm indicator chirp. If alarms are sus-
pected of mis-operating, contact your distributor for veri cation that alarms are working correctly. 7.8. Turning O CAUTION: Always turn o this device when not in use. To turn the Zen-Olite Portable Oxygen Concentrator o , press and hold the power but-
ton. The device will chirp and the screen will display a shutdown message for approximately ve seconds, then go into low-power mode. IMPORTANT: Do not disconnect the AC power supply and remove the battery at the same time while the unit is running. Always use the power button to turn the device o . Wait until the device has completely shut down before disconnecting from power and removing the battery. 8. TRAVELING WITH THE ZENOLITE POC BY AIR 8.1. Passenger Pre- ight Preparation 8.1.1. Required Labeling Your Zen-Olite POC is suitable for aircraft use and has met all acceptance criteria of the United States Federal Aviation Administration (FAA). This is veri ed by the statement on the back of the POC that states, in red text, The manufacturer of this POC has deter-
mined this device conforms to all applicable FAA acceptance criteria for POC carriage and use on board aircraft. Prior to the ight, you may be asked to show this text on the POC to the ight attendant. 18/316 EN 8.1.2. Healthcare Provider Consultation The FAA does not require a passenger to consult with a healthcare provider prior to us-
ing a Zen-Olite POC on board an aircraft. However, you, together with your healthcare provider, may wish to discuss the following:
The e ects of a pressurised cabin (cabin pressure altitude can reach 8,000 feet) on your oxygen needs.
- Some Zen-Olite POC users need higher litre ow or litre per minute (LPM) setting for the Zen-Olite POC in the air because of cabin pressure altitude.
- Some Zen-Olite POC users who use a Zen-Olite POC occasionally on the ground may need to use their Zen-Olite POC for the entire ight because of cabin pressure altitude. Your oxygen needs at the time of travel and whether your needs have changed since the Zen-Olite POC was rst prescribed or during the most recent consultation with a healthcare professional. Certain button provisions in the Zen-Olite POC operating manual regarding oxygen delivery, indicators, warnings, and alerts, as well as setting/changing litre ow or LPM. All crewmembers (pilots and ight attendants (F/A)) receive training regarding the han-
dling of in- ight medical events. However, the FAA does not require that air carriers or crewmembers provide medical assistance to passengers. IMPORTANT: Additional information regarding passenger health and safety can be found at http://www.faa.gov/passengers/ y_safe/health/comprehensive/. 8.1.3. Determine a Su cient Number of Batteries You are responsible for bringing a su cient number of batteries to power the Zen-Olite POC for the duration of the expected use of your Zen-Olite POC. You should consider at least the following in determining a su cient number of batteries:
Healthcare professional advice regarding duration of Zen-Olite POC use. Air carrier information regarding duration of the expected ight as well as any layovers and unanticipated delays. IMPORTANT: You may be ying on multiple ights or multiple airlines, which could also involve extended periods of Zen-Olite POC use on the ground between ights. Zen-Olite owners manual information regarding expected duration of battery power. IMPORTANT: You should never rely upon available onboard aircraft electrical power dur-
ing a ight. Air carrier requirements to carry a certain amount of batteries are typically available on each airlines web site. IMPORTANT: Air carriers may require you to bring enough batteries to power the device for at least 150% of the expected maximum ight duration. 19/316 EN 8.1.4. Documentation You are responsible for the operation of the Zen-Olite POC on board the aircraft. For this reason, the FAA recommends that passengers carry with them, at minimum, this User Manual and any other written information provided by your healthcare professional regarding the Zen-Olite POC and its use. 8.1.5. Physicians Statement An air carrier may require a medical certi cate from a passenger with a disability if there is reasonable doubt that the individual can complete the ight safely without requiring extraordinary medical assistance during the ight. Also, an air carrier may require a medi-
cal certi cate from a person who needs medical oxygen during a ight. The FAA does not require passengers to obtain a physicians statement and present such statement to the operator or pilot in command (PIC) prior to Zen-Olite POC use on board the aircraft. 8.1.6. Spare Batteries Battery damage and battery short circuit can result in battery overheating and re. These events, in turn, can result in personal injury to passengers, and in the worst case for cer-
tain types of batteries, a catastrophic passenger compartment re. Thus, spare lithium batteries carried on board aircraft must be individually protected from short circuit by placement in original retail packaging, by taping over exposed terminals, or by placing each battery in a separate plastic bag / protective pouch. IMPORTANT: Spare lithium batteries are prohibited from being carried in checked bag-
gage on an aircraft. You are responsible for ensuring that all spare batteries carried in carry-on baggage are properly packaged. Zen-Olite POC equipment providers, some airlines, and freight for-
warders specialising in small package shipments may provide this packaging service for you. 8.2. Boarding and In- ight Information 8.2.1. Carry-on baggage Your Zen-Olite POC is an assistive device. In this case, carriers shall not, in implement-
ing their carry-on baggage policy, count the Zen-Olite POC toward a limit on carry-on items brought into the cabin by a quali ed individual with a disability. IMPORTANT: A bag with additional batteries that is required to power the Zen-Olite POC during the ight could also be considered an assistive device. However, there are restrictions on the Watt Hour (Wh) rating of the battery which is limited to 100Wh per bat-
tery. For your Zen-Olite POC, the Watt Hour (Wh) rating is less than 100Wh per battery maximum, therefore no limitation will be imposed. 20/316 EN 8.2.2. Zen-Olite POC as Checked Baggage Your Zen-Olite POC may be carried on aircraft as a carry-on or as checked baggage. However, spare lithium batteries are prohibited from being carried in checked baggage on an aircraft. 8.2.3. Considerations Regarding Placement and Stowage of your Zen-Olite POC In order for a Zen-Olite POC to work e ciently, the air/intake vents must not be blocked during use. Therefore, the area around the Zen-Olite POC should be clear of blankets, coats, and other pieces of carry-on baggage that may block the air/intake vents. If the air/intake vents are blocked, two things will occur. First, you will be alerted by warning lights and/or audible alerts that the oxygen concentration in the Zen-Olite POC output is insu cient. Second, when the temperature of the Zen-Olite POC internal compo-
nents increases to a certain limit because the Zen-Olite POC is still trying to dispense oxygen, the Zen-Olite POC will automatically shut down to prevent overheating of the Zen-Olite POC and you will be alerted by warning lights and/or audible alerts. Placement of Zen-Olite - Onboard an aircraft the Zen-Olite POC should be placed underneath the seat in front of you so that you or the ight attendant can see the warn-
ing lights and/or hear the audible warning. Placement directly under your seat and place-
ment in a closed compartment would prohibit you from seeing the warning lights, as well as possibly prohibiting you from hearing audible warnings. Other placement locations may be acceptable as deemed acceptable by the ight attendant. 8.2.4. Seating Restrictions for Passengers who Plan to use a Zen-Olite POC On Board an Aircraft Exit Row Seating - The FAA prohibits passengers that use any assistive device including Zen-Olite from occupying an exit seat. Stowage during Aircraft Movement - During movement on the surface (pushback from the gate and taxi), take-o , and landing, the Zen-Olite POC must be stowed properly and in such a manner that it does not restrict passenger access to any exit or the aisle in the passenger compartment. Additional seating restrictions may be necessary to comply with these FAA safety rules. For example:
1. Some seats on an aircraft, such as bulkhead seats, may or may not have approved stowage space to accommodate a Zen-Olite POC during movement on the surface, take-o , and landing. Therefore, the Zen-Olite POC may not be able to be stowed properly during these phases of ight if the Zen-Olite user occupies those seats. In this case, a seating restriction may apply 21/316 EN 2. During movement on the surface, take-o , and landing, the nasal cannula tubing that is used to dispense oxygen from your properly stowed Zen-Olite POC may not stretch across the row in such a way as to restrict passenger access or become a tripping hazard in an evacuation. You must not restrict another passengers access during these phases of ight. In this case, a seating restriction may be required to comply with an FAA safety rule. For example, if all seats in the row are occupied, the appropriate seat for the Zen-Olite POC user would be a window seat. 3. An operator can only establish seating restrictions based on FAA safety rules. The examples above represent some, but not all, scenarios to consider. IMPORTANT: A general airline policy that all passengers who board the aircraft with a Zen-Olite POC must occupy a window seat, without regard to the speci cs of the indi-
vidual situation, would be inconsistent with FAA requirements. 8.2.5. Cabin Depressurisation There is no danger posed by a Zen-Olite POC that is operating during a loss of cabin pressure. However, in the case of loss of cabin pressure (rapid or slow), you should use the oxygen masks that deploy until the aircraft stabilises. 8.2.6. Use of Aircraft Electrical Power There is no requirement for operators to provide aircraft electrical power to a Zen-Olite POC user. Electrical outlets on board aircraft are considered nonessential equipment and are not required by the applicable certi cation or operational rules. In addition, electrical malfunctions in aircraft systems may require the power source to these outlets to be de-
activated on the ground or in ight for the safety of the ight. Due to this statement, the Zen-Olite POC should only be operated o battery power while on board aircraft. You should never rely upon onboard aircraft electrical power being available during a ight 8.2.7. Smoking Smoking (including e-cigarettes) during oxygen therapy is dangerous and is likely to re-
sult in serious injury or death of the patient and others from re. Do not allow smoking or open ames within 10 feet of the portable oxygen concentrator or any oxygen carrying accessories. 8.3. Transportation Security Administration (TSA) Requirements Detailed information that is pertinent to passengers using respiratory devices, including Zen-Olite POCs, may be obtained from the TSA at https://www.tsa.gov/travel/special-
procedures. The following general security screening considerations apply to Zen-Olite POCs:
1. The limit of one carry-on and one personal item (e.g., purse, briefcase, or computer case) does not apply to medical supplies, equipment, mobility aids, and/or assistive devices carried by and/or used by a person with a disability. 22/316 EN 2. If a person has medical documentation regarding their medical condition or disabil-
ity, they can present this information to the screener to help inform him or her of the persons situation. This documentation is not required and will not exempt a person from the security screening process. 8.4. Placing your device in Airplane Mode If you have the RS-00600C model (this is stated on the back of your device), this means your device is connected to GCE's Clarity platform. Clarity provides regular updates on your device's performance to your home oxygen provider, enabling them better support you and your device. When travelling by air, you are required by international air travel regulations to disable communications features on your electronic devices on board the aircraft. If your Zen-O portable oxygen concentrator is enabled to work with GCE's Clarity platform you will need to place the device in Airplane mode. You can do this in few easy steps:
1. To place in Airplane Mode: Press and hold both Mute Minus buttons and for 4 seconds. 2. The screen will display as follows:
and the power/battery symbol will alternate with "A":
3. If a button is pressed, the display shows as normal and after 10 seconds it reverts to the con-
tinuously alternating A 4. To disable the Airplane Mode: Press and hold both Mute for 4 seconds. and Minus buttons IMPORTANT: Activating or de-activating the Airplane mode does not a ect the normal operating performance of your device, continue to use your device as normal. 23/316 9. ALARM INDICATORS If the Zen-Olite Portable Oxygen Concentrator detects an alarm condition, it will indi-
cate the alarm visually and audibly within 10 seconds. There are four levels of alarms:
critical high priority, high priority, medium priority, and low priority. Each is indicated di erently by the backlit display; yellow, and red LEDs; and buzzer, as indicated below. In each case, the alarm message and power status will override the cur-
rent display. IMPORTANT: All alarm conditions and parameters are factory preset; conditions and parameters cannot be changed or adjusted by the user. IMPORTANT: The alarm system is tested during the startup sequence. You should see all alarm lights brie y turn on and the audible alarm indicator chirp. EN Alarm status Audible Tone High priority Critical high priority Ten beeps per burst, burst repeats every 3 seconds. Ten beeps per burst, burst repeats every 3 seconds. Three beeps per burst, burst repeats every 8seconds Three beeps per burst, burst repeats every 10minutes Medium priority Low priority Visual Indicator Solid red LED and device is automati-
cally disabled Flashing red LED Mute Time 20 minutes 20 minutes Flashing yellow LED 8 hours Solid yellow LED 24 hours IMPORTANT: If two alarm conditions exist at the same time, the highest priority alarm is indicated. If two or more alarm conditions of equal priority exist at the same time, the most recent one will be displayed. IMPORTANT: The most recent alarms indicated by the device are logged for reference by service personnel. This log is maintained even if the device is powered down or if power is lost for any other reason. IMPORTANT: If the mute button is pressed prior to an alarm condition (for example, to mute the device in a movie theatre), critical high priority and high priority alarms will override the mute function; medium and low priority alarms will be muted for eight hours and twenty four hours respectively from the time the button was pressed. Press the mute 24/316 button o to display the last highest priority alarm. Press the mute button on again to reset the eight-hour timer. 9.1. Alarms When the concentrator sounds an alarm, a corresponding message will be displayed on the screen. Take appropriate action as directed in the charts below. 9.1.1. Critical High Priority Alarms IMPORTANT: These alarms will disable the device immediately. Alarm message Action EN Description Battery needs charging. Battery is not an approved battery. Service required. Recharge the battery pack by plugging in to the power supply. Ensure all connections are made securely. Replace battery with an approved battery. Contact your distributor.
*Value: 01-20 9.1.2. High Priority Alarms IMPORTANT: These alarms will allow the device to continue operating. Alarm message Description Action Device is unable to maintain oxy-
gen purity. Estimated battery life less than 17 minutes. Service required.
*Value: 21-50 25/316 Be sure air inlet/outlet has not been blocked. If alarm persists, contact your distributor. Charge the battery pack by plug-
ging in to power supply. Important: The message will be automatically cleared when plugged in to power supply. Contact your distributor. 9.1.3. Medium Priority Alarms Alarm message Description No breath detected for 60 seconds EN Service required.
*Value: 51-70 9.1.4. Low Priority Alarms Alarm message Description Service required.
*Value: 71-99 9.1.5. Other Messages Message Description External power has been discon-
nected; unit is now running on battery. Displayed while unit goes through its power-down sequence. Displayed as the battery menu item when there are no communi-
cations with the battery. 26/316 Action Check the cannula connection. Be sure to breathe through nose, If alarm persists, contact your distributor. IMPORTANT: The message will be automatically cleared when breathing is detected. Contact your distributor. Action Contact your distributor. Action No action is required. No action is required. Verify that the battery pack is correctly installed. Contact your distributor if the battery is fully inserted and the message contin-
ues to be displayed longer than 30 seconds. Displayed percentage of battery charge if at least 10% and there is no external power connected. NN% displays the current battery charge level. Displayed when battery charge is greater than 10% but less than 100% and there is external power connected. Battery charge is less than 10%
and there is external power connected. The patients average breath rate when the device is delivering the maximum amount of oxygen and the bolus is reduced. If no breaths are detected, the most recent breath rate is shown. A previously set alarm has been automatically cleared. Message is displayed when bat-
tery button is pressed. Message is displayed when bat-
tery button is pressed. Message is displayed when bat-
tery button is pressed. Reduced activity level. Be sure air inlet/outlet has not been blocked. IMPORTANT: The message will automatically clear when the de-
vice returns to normal operation. No action required. EN 10. TROUBLESHOOTING Problem System becomes inoperative Possible Cause Troubleshooting Check that the system is connected securely to the power source. Ensure the system is powered on. Examine the system for damage or exposure to liquids. If problem persists, contact your distributor. System may be dis-
connected from the power source. System may be turned o . Critical high priority alarm has occurred. 27/316 Any alarm sound or either See Chapter 9 -
Alarm Indicators. See Chapter 9 - Alarm Indicators. or LED lit EN Battery not charging Power is not connected. Battery is not fully inserted. Battery is inoperable. Check connections to ensure:
Round receptacles are secure in unit. Power cord is connected to AC/DC supply or automotive DC adapter is connected, if applicable. Power cord is connected to wall outlet, if applicable. Wall outlet has power. Ensure battery is fully seated and battery cover is secure. If problem persists, contact your distributor. 11. MAINTENANCE AND CLEANING 11.1. Routine Maintenance WARNING: Do not use lubricants on this device or any of its accessories. CAUTION: Replace the cannula on a regular basis. Check with your distributor or clini-
cian to determine how often the cannula should be replaced. Device will indicate with an alarm when service is required. (Also, see Chapter 10 - Trou-
bleshooting.) No special maintenance needs to be carried out by the user. Contact your provider or manufacturer for help, in setting up, maintenance, or to report unexpected errors. 11.2. Cleaning and Disinfection WARNING: Do not submerge this device in liquid. Do not expose to water or precipita-
tion. Do not expose to dusty conditions. 28/316 CAUTION: Do not use cleaning agents other than those speci ed in this manual. Allow the cleaning solution to dry from the cleaned surface before use. CAUTION: Always disconnect power and turn o this device before cleaning. Clean the exterior with a soft cloth slightly dampened with soapy water or with anti-bac-
terial wipes (Isopropyl alcohol 70% solution). For disinfecting, use a MadaCide-FDW-Plus wipe or equivalent and follow the manufac-
turer's instructions. (Manufacturer - Mada Medical Products Inc., www.madamedical.com) Important: The device should receive an external cleaning weekly, accessories should be cleaned as needed. The device exterior and accessories should be cleaned and dis-
infected and the patient lter replaced prior to delivering to a new patient. The device may become hot after operation, take additional care when replacing lters. Nasal cannula: Refer to the original manufacturer's instructions for cleaning the nasal cannula. 11.3. Service Life The expected service life of the device is 5 years, except for the sieve modules. The service life of the sieve modules will depend on the operating conditions. Replace them as need-
ed, indicated by the check vents alarm. If intake and exhaust vents are not blocked and the check vents alarm persists, contact your distributor for instructions on replacing the sieve modules. 11.4. Service Connector The service connector mates with service harness TF-02091
(5.1 Vdc maximum) and is utilised for service only. EN 12. DEVICE REPAIR AND DISPOSAL Fig. 8 12.1. Repair Do not attempt to repair the device. Contact your home oxygen provider or distributor for assistance (see Chapter 10 - Troubleshooting). The sieve modules may be replaced by the patient as determined by the home oxygen provider or distributor. All other maintenance or repair must be performed by trained service personnel. 12.2. Sieve Modules Replacement Instructions:
1. Turn o and disconnect AC or DC power the device source
(if connected). 2. Remove the device from the carry bag. 29/316 EN 3. Remove the battery from the device. 4. Press the four release buttons located at the top of the de-
vice to remove the top cover of the device as shown in Fig. 9. 5. Use the tool included with the replacement sieve modules Use the tool included with the replacement sieve modules package to rotate the sieve counter clockwise 3 - 4 turns until it can be removed by pulling up towards the top of the device. 6. Repeat for the second sieve module. 7. Remove the replacement sieves from the packaging, re-
move the air plug on the sieve module and immediately in-
stall the replacement sieve module. Caution: Do not leave the replacement sieve exposed. 8. Install the replacement sieve, with thread at the top of the device as shown in Fig. 10. 9. Hand tighten the sieve. 10. Use the tool to nish installing. CAUTION: Do not over-tighten!
11. Repeat steps 8 - 10 for the second replacement sieve. 12. Re-install the top cover to the device by pushing down over the top of the device until the four buttons snap into place. 13. Re-insert the battery into the device. 14. Connect the device to an AC or DC power source. Fig. 9 Fig. 10 DO NOT POWER ON!
15. Press the alarm mute and battery buttons simultaneously until the displays shows "Leak Test". a. The device will indicate progress by decimals right of the "Leak test" text. b. When completed, the device will indicate "Test Passed" or "Test Failed". i Test Passed - Press battery button ii Test Failed - Press battery button to exit, continue to step 16. to exit, then repeat steps 4-15. 16. If the leak test has passed, then clear the device sieve hour counter. a. Turn on your Zen-O lite portable oxygen concentrator. b. Simultaneously press the c. Press the and or displayed, where XXXX = number of hours for the old sieve was utilised. button to navigate he diagnostic menu until "XXXH Sieve" is buttons until "Diagnostics" is displayed. d. Press the alarm mute button until the sieve hour counter shows "0H Sieve". 30/316 e. Press the battery button f. The device is now ready to be used. to exit the diagnostic mode. Important: Contact your home oxygen provider or distributor if the device does not pass after multiple attempts. 12.3. Disposal Contact your distributor regarding disposal of the device. Dispose of battery according to local regulations or contact your distributor. 13. WARRANTY The device warranty is limited to three (3) years from date of sale to GCEs customer, this excludes the sieve modules which have only one year warranty. All accessories including batteries are limited to one (1) year warranty. The standard warranty is only valid for products handled as stated in the user manual and in accordance with general industry good practice and standards. EN 14. TRADEMARKS AND DISCLAIMER 14.1. Trademark All trademarks are the property of their respective owners. 14.2. Disclaimer The information in this document has been carefully examined and is believed to be reli-
able. Furthermore, the manufacturer reserves the right to make changes to any products herein to improve readability, function, or design. The manufacturer does not assume any liability arising out of the application or use of any product or circuit described herein;
neither does it cover any license under its patent rights nor the rights of others. 14.2.1. This Document The information in this document is subject to change without notice. This document contains proprietary information that is protected by copyright. No part of this document may be reproduced in any manner, in whole or in part (except for brief excerpts in reviews and scienti c papers), without the prior written consent of the manufacturer. Be sure to read carefully and understand all manuals provided with the product. For Help If you have questions about the information in these instructions or about the safe opera-
tion of this device, contact your home oxygen provider or distributor. 31/316 EN 15. TECHNICAL DESCRIPTION Size:
Unit weight:
Power requirements:
Purity:
Setting:
Inspiratory trigger sensitivity:
Setting indicator:
Maximum oxygen discharge pressure:
Humidity range:
Disconnect Device:
Operating altitude:
Sound level:
249 mm (W), 97 mm (D), 235 mm (H) 9.8" (W), 3.8" (D), 9.25" (H) 2.5 kg (5.5 lbs) (without carry bag) AC adaptor: 100-240V AC (+/- 10%), 50-60 Hz in, 24V DC, 5.0A out. DC adaptor: 11.5-16V DC in, 24V, 5.0Aout
(Important: see accessories list for model and part numbers for AC and DC power supply packs.) 87% - 96% at all ow rates, over operating conditions User adjustable in 0.5 increments from 1.0 to 5.0.
-0.12 cm/H2O LCD 20.5 psi 5% to 93% 2% non-condensing Power supply input connector 0m to 4,000m (0 to 13,000) relative to sea level, 1060 down to 575 mbar Sound Pressure level of 37dBA at setting 2 and 18 BPM:
(when measured at 1 m from front of device) Sound Pressure level of 48.7dBA/Sound Power level of 56.7dBA at setting 5 Type of protection
(electrical):
Degree of protection
(electrical):
Class II Type BF 32/316 EN Degree of protection
(water):
IP22 in carry bag (protection against small objects and tilted dripping water) IP20 out of carry bag (protection against small objects and no protection against water entering the concentrator) Not suitable for use in the presence of a ammable anaes-
thetic mixture Continuous operation at temperatures between 5C (41F) and 40C (104F). Degree of safety
( ammable anaesthet-
ic mixture):
Operating temperature:
Storage temperature: Between -20C (-4F) and 60C (140F). Alarm sound pressure range:
Alarm system delays:
68.1 to 69 dB(A) Less than 10 seconds after detection (low oxygen alarms if oxygen is less than 82% volume fraction at speci ed environ-
mental conditions) High priority alarm that indicates when oxygen concentration drops below 82%
Oxygen concentrator status indicator:
Pulse mode bolus size (ml/breath) versus setting and breath rate Breath per minute 15 20 25 30 35 40 1 11 11 11 11 11 11 2 22 22 22 22 22 22 Setting 3 33 33 33 33 30 26.3 4 44 44 42 35 30 26.3 5 55 52.5 42 35 30 26.3 All values +/- 15% over all operating conditions 33/316 EN Eco Mode bolus size (ml/breath) versus setting and breath rate Breath per minute 15 20 25 30 35 40 1 14 10.5 8.4 7 6 5.25 2 26.4 19.8 15.8 13.2 11.3 9.9 Setting 3 42 31.5 25.2 21 18 15.75 4 56 42 33.6 28 24 21 5 70 52.5 42 35 30 26.25 All values +/- 15% over all operating conditions 15.1. Electromagnetic Compatibility (EMC) Information Medical electrical equipment requires special cautions regarding electromagnetic com-
patibility (EMC). Portable and mobile radio frequency (RF) communications equipment can a ect devices such as the Zen-Olite Portable Oxygen Concentrator. As such, the device should not be used adjacent to other equipment. If this is not practical, then ob-
serve the device to make sure it is operating properly at all times. 15.1.1. Guidance and manufacturers declaration: electromagnetic emissions The Zen-Olite Portable Oxygen Concentrator is intended for use in the electromagnetic environment speci ed below. The customer or the user of the concentrator should en-
sure that it is used in such an environment. Emission test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage uctuations/
icker emissions IEC 61000-3-3 Compli-
ance Group 1 Class B Class A Complies Electromagnetic environment/guidance The Zen-Olite Portable Oxygen Concentrator uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The concentrator is suitable for use in all establish-
ments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for do-
mestic purposes. 34/316 15.1.2. Guidance and Manufacturers Declaration: Electromagnetic Immunity Zen-Olite is intended for use in the electromagnetic environment speci ed below. The customer or the user of the concentrator should assure that it is used in such an environ-
ment. Immunity test Electromagnetic environment/
IEC 60601 test Compliance level level guidance EN Electrostatic discharge
(ESD) IEC 61000-4-2 2, 4, 6, 8kV contact 2, 4, 8, 10, 15kV air 2, 4, 6, 8kV contact 2, 4, 8, 10, 15kV air Electric fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interrup-
tions, and volt-
age variations on power supply input lines IEC61000-4-11 2kV for power supply lines 1kV for input/
output lines 1kV di erential mode 2kV common mode
< 5% UT
(>95% dip in UT) for 0.5 cycle 40% UT
(60% dip in UT) for 5 cycles 70% UT
(30% dip in UT) for 25 cycles
<5% UT
(>95% dip in UT) for 5 sec 2kV for power supply lines 1kV for input/
output lines 1kV di erential mode 2kV common mode
< 5% UT
(>95% dip in UT) for 0.5 cycle 40% UT
(60% dip in UT) for 5 cycles 70% UT
(30% dip in UT) for 25 cycles
<5% UT
(>95% dip in UT) for 5 sec Floors should be wood, concrete, or ceramic tile. If oors are covered with synthet-
ic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the Zen-O lite Portable Oxygen Concentrator required continued operation during power main inter-
ruptions, it is recommended that the concentrator be powered from an uninterruptible power supply or battery. 35/316 Power frequency
(50/60 Hz) magnetic eld IEC 61000-4-8 Immunity test Conducted RF IEC 61000-4-6 EN 30 A/m 30 A/m IEC 60601 test level Compliance level 3 Vrms
(6Vrms ISM Bands) 3 Vrms 150 kHz to 80 Mhz ;
6Vrms ISM Bands 10 V/m 80 Mhz to 2.5 Ghz 10 V/m Radiated RF IEC 61000-4-3 IMPORTANT: At 80 MHz and 800 MHz, the higher frequency range applies. IMPORTANT: These guidelines may not apply in all situations. Electromagnetic propagation is a ect-
ed by absorption and re ection from structures, objects, and people. aField strengths from xed transmitters, such as base stations for radio (cellular/cordless) tel-
ephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the Zen-Olite is used exceeds the applicable RF compliance level above, the concentrator should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the concentrator. bOver the frequency range 150 kHz to 80 MHz, eld strengths should be less than 6 V/m. 36/316 Power frequency magnetic elds should be at levels characteristic of a typical commercial or hospital environment. Electromagnetic environment/
guidance Portable and mobile RF commu-
nications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation ap-
plicable to the frequency of the transmitter. Recommended separation distance:
d = 1.2 P 150 kHz to 80 MHz d = 1.2 P 80 MHz to 800 MHz d = 2.3 P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the trans-
mitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from xed RF trans-
mitters, as determined by an elec-
tromagnetic site surveya should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:
15.1.3. Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Zen-Olite Portable Oxygen Concentrator The Zen-Olite Portable Oxygen Concentrator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The concentrator user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the concentrator as recommended below, according to the maximum output power of the communica-
tions equipment. Rated max. output power of transmit-
Separation distance (m) according to frequency of transmitter 800 MHz to 2.5 150 kHz to 80 MHz 80 MHz to 800 EN ter (W) 0.01 0.1 10 100 d = 1.2 P 0.12 0.38 3.8 12 MHz d = 1.2 P 0.12 0.38 3.8 12 d = 2.3 P GHz 0.23 0.73 7.3 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Important: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Important: These guidelines may not apply in all situations. Electromagnetic propaga-
tion is a ected by the absorption and re ection from structures, objects, and people. 15.2. FCC WARNING STATEMENT FOR MODEL RS-00600C This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference that may cause undesired operation. This equipment complies with FCC radiation exposure limits set forth for an uncon-
trolled environment when used in the supplied carry bag or when used in a non-me-
tallic accessory that maintains a minimum 8mm separation distance from the side. End users must follow the speci c operating instructions for satisfying RF exposure compli-
ance. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. 37/316 Changes or modi cations not expressly approved by the party responsible for compli-
ance could void the user's authority to operate the equipment. 15.3. EU RED ARTICLE 10(10) RESTRICTIONS ON USE FOR MODEL RS-00600C:
Based on the information available from the European Communication O ce (ECO) Fre-
quency Information System (EFIS), Zen-O lite (model RS-00600C) complies with stipulat-
ed radio frequency radiation limits. The table below demonstrates compliance to Article 10 (10) of the European Union Radio Equipment Directive (RED) and con rms that there are no restrictions with regards to its use by patients in member states of the European Union;
RF Transmitter Information:
Function /
Band Usage Uplink /
Transmit
(MHz) Downlink /
Receive
(MHz) Modulation Scheme Maximum E ective Radiated Power
(ERP/EIRP) EN LTE band 1 UMTS band 1 LTE band 3 LTE band 7 LTE band 8 UMTS band 8 UMTS band 9 LTE band 20 LTE band 28 EGSM 900 DCS 1800 GPS Bluetooth 1920 1980 2110 2170 QPSK/16QAM 24 dBm / 0.25 W 1710 1785 2500 2570 880 915 1805 1880 2620 2690 925 960 QPSK/16QAM QPSK/16QAM QPSK/16QAM 23 dBm / 0.20 W 23 dBm / 0.20 W 24 dBm / 0.25 W 1749.9 1784.9 1844 1879.9 832 862 703 748 890.0 915.0 1710.2 1784.8 N/A 2400 2483 QPSK/16QAM QPSK/16QAM 791 821 758 803 QPSK/16QAM 935.0 960.0 GMSK/8PSK 1805.2 1879.8 GMSK/8PSK 1559 1610 2400 2483 23 dBm / 0.20 W 23 dBm / 0.20 W 23 dBm / 0.20 W 33 dBm / 2.0 W 30 dBm / 1.0 W CDMA / FDMA Receive Only GFSK / /4-
DPSK / 8-DPSK 2.2dBm / 0.002 W 15.4. RF EXPOSURE INFORMATION:
The RS-00600C model meets the applicable limits for radio frequency (RF)exposure, as determined by independent tests for the Speci c Absorption Rate (SAR). Speci c Absorption Rate (SAR) refers to the rate at which the body absorbs RF energy. 38/316 The SAR limit is 1.6 watts for kilogram in countries that set the limit averaged over 1 gram of tissue and 2.0 watts per kilogram in countries that set the limit averaged over 10 grams of tissue. The highest SAR values measured in accordance with ICNIRP guidelines for this device with an 8mm separation as provided by the carry bag are:
Body SAR at 1g: 1.50 W/Kg Body SAR at 10g: 1.81 W/Kg During use the actual SAR values for this device are usually well below the values stated above because for purposes of system e ciency operating power is reduced from full when not needed and the lower the power output the lower its SAR value. EN 16. GLOSSARY EXPLANATION OF PACKAGING AND LABELLING SYMBOLS See Instructions Before Use Type BF according to electri-
cal safety requirements Serial Number Catalogue Number U.S. federal law restricts this device to sale by or on the order of a physician Do not use if packaging is damaged (See Chapter 6) No open ame when device is in use or do not incinerate SN REF No Open Flames Operating atmospheric pres-
sure limitation 0 to 13,000
(0 Kpa to 50.2 Kpa) Storage temperature limita-
tion -20C to 60C (-4F to 140F) Humidity limitation 5% to 93% 2% non-condensing Handle with care Date of manufacture Manufacturer Keep dry (This symbol refers to the IPX2 classi cation of the device) Do not get wet IP20 39/316 No Smoking No smoking Separate collection for electrical and electronic equipment Complies with applicable EU Directives including Medical Device Directive EN Dispose of used battery properly Class II symbol Suitable for homecare use 40/316 EN GCE Ltd 100 Empress Park, Penny Lane, Haydock, St Helens WA11 9DB United Kingdom 0088 Manufactured for: GCE Ltd Jesus Siqueiros #652, 83170 Hermosillo, Mexico 41/316
This product uses the FCC Data API but is not endorsed or certified by the FCC